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dentistry.ucsf.edu dentistry.ucsf.edu Presentation Transcript

  • Prevention Management Model for ECC “MAYA Project” Francisco Ramos-Gomez, DDS, MS, MPH Associate Professor Division of Growth and Development UCSF - NIDCR Center for Disparities Grant
  • TEAM MEMBERS “MAYA”
    • Jane Weintraub
    • Stuart Gansky
    • Susan Millstein
    • Karen Duderstadt
    • Ed Martinez
    • Cynthia Anaya
    • Rocio Valenzuela
    • Joachim Reimann
    • Gregory Talavera
    • Brian Scheff
    • Liz Keays
  • Specific Aims
    • Primary aim is to evaluate two programs, a minimal intervention program and a moderately intense intervention program, for preventing ECC
    • 1) Assess efficacy of a disease prevention management model by analyzing demographic data as predictors of ECC, and by analyzing the relationship between three-year post-intervention data and behavioral changes.
  • Specific Aims
    • 2) Compare efficacy for prevention of ECC in two groups: the minimal intervention group (Group 1) and the moderate intensity intervention group (Group 2)
      • Group 1 - receives counseling
      • Group 2 - receives counseling and a therapeutic three month regimen of chlorhexidine rinse for new mothers and fluoride varnish applications for their infants and toddlers from 12 - 30 months of age
  • Specific Aims
    • 3) Assess baseline salivary microbiological markers as predictors of ECC in the infants of women in both groups and the relationship between three-year post-intervention salivary markers and changes from baseline measures
    • 4) Assess the impact of a caries-prevention model in lowering the salivary mutans streptococci level in post-partum women, and inhibiting the growth of these bacteria in their young children
  • Multi-agency - Team Sites
    • University of California, San Francisco
    • San Ysidro Community Health Center
    • San Diego State University
    • University of California, San Diego
  • Research Design and Method
    • Seven years project
    • Four year randomized clinical trial
    • First year start-up planning period: recruit/train staff, test materials, write procedure manuals, screen potential participants.
    • 512 women in sixth month of pregnancy are being recruited from San Ysidro Community Health Center
  • Research Design and Method
    • Women randomly will be assigned to Group 1 or Group 2
    • Group 1 receives counseling
    • Group 2 receives counseling and chlorhexidine rinses; babies receive dental exams and fluoride varnish applications
  • Research Design and Method
    • Treatment provided at routine child care visits
    • Information provided in appropriate language (English or Spanish)
    • Women recruited in second trimester of pregnancy
    • Eligibility criteria includes evidence of geographic stability
  • MAYA Outreach Activities
  • MAYA Recruitment
  • MAYA Race 03 Part A. TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race Ethnic Category Sex/Gender Female Males Unknown Total Hispanic or Latino 48 0 0 48 Not Hispanic or Latino 4 0 0 4 Other 0 0 0 0 Ethnic Category: Total of All Participants 52 0 0 52           Racial Categories         American Indian /Alaska Native 0 0 0 0 Asian 0 0 0 0 Native Hawaiian / Pacific Islander 0 0 0 0 African American / Black 2 0 0 2 Caucasian / White 0 0 0 0 Other 43 0 0 43 No Response 0 0 0 0 More than one race 7 0 0 7 Racial Category: Total of All Participants 52 0 0 52
  • MAYA Race 03 PART B. HISPANIC ENROLLMENT REPORT: Number of Hispanics or Latinos Enrolled to Date (Cumulative) Racial Categories Females Males Unknown Total American Indian /Alaska Native 0 0 0 0 Asian 0 0 0 0 Native Hawaiian / Pacific Islander 0 0 0 0 African American / Black 0 0 0 0 Caucasian / White 0 0 0 0 Other 41 0 0 41 No Response 0 0 0 0 More than one race 7 0 0 7 Racial Category: Total of Hispanics or Latinos 48 0 0 48
  • CONSENT TO PARTICIPATE IN THE MAYA PROJECT
  •  
  • Dr. Francisco Ramos-Gomez, a pediatric dentist from the Department of Growth and Development at UCSF and Cynthia Anaya, RDH, MAYA Project Director at San Ysidro Health Center. Are conducting a study to learn how to stop a type of tooth decay: Early Childhood Caries (ECC) STUDY PURPOSE AND BACKGROUND : P age 1
    • You need to be in your 2nd. Trimester of pregnancy
    • You need to be registered in SYHC
    • You must p lan to deliver your baby in the United States
    • You must be responsible at keeping appointments
    • You must plan to reside in the South Bay area (39 months)
    • You must be w illing to answer to some questions related to your health
    • You must be w illing to use an anti-microbial mouth rinse if chosen in Group II.
    • You must be willing to allow us to use a small amount of yours and your child’s saliva to be analyzed and determine risk of tooth decay.
    Requirements to participate : P age 1
  • 1.- Your and your baby’s medical records will not be reviewed as part of this study. 2.- You and your baby will be randomly assigned (like a flip of a coin). 3.- Treatments we offer: a) Oral health counseling b) Periodic dental screenings c) Oral Rinse (Oral medicine) d) Dental exams for mother and child e) Fluoride varnish (beginning at 1 year of age) DESCRIP T ION OF THE STUDY PARTICIPATION : * Length of the study: Approximately 39 months. P age 1
  • Issues for MAYA Website development Data management issues Discuss DSMB recommendation (WSL) Questionnaire development Interaction with Behavioral Scientists MAYA Clinical Trial Advisory Board Retention of Women in the study